MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL; ANESTHESIA CONDUCTION KIT

Model Number A1240-18

Device Problems Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Code Available (3191)

Event Date 10/11/2017

Event Type  malfunction  

Event Description

During recovery, the rn attempted to remove the epidural catheter from the spine per standard protocol.The rn met slight resistance and repositioned the patient for ease of removal.It was noted, the tip was not intact upon assessment.

• Brand Name: PORTEX CONTINUOUS EPIDURAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman drive; keene NH 03431
• MDR Report Key: 7577659
• MDR Text Key: 110358842
• Report Number: 7577659
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2018
• Device Model Number: A1240-18
• Device Catalogue Number: A1240-18
• Device Lot Number: 3447740
• Other Device ID Number: 18G CRAWFORD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 23 YR
• Patient Weight: 58